The delivery of nutritional compositions to animals, such as human patients, that cannot orally ingest food or other forms of nutrition is often of critical importance. For example, feeding tubes that deposit food directly into the gastrointestinal tract at a point below the mouth are often used to sustain life while a patient is unable, or refuses, to take food orally. Feeding tubes and other artificial delivery systems and routes can be used temporarily during the treatment of acute conditions. For chronic conditions, such systems and routes can be used as part of a treatment regimen that lasts for the remainder of a patient's life. No matter the duration of use, these devices often provide the only means for feeding the patient.
Fluid nutritional compositions, frequently referred to as ‘formula,’ are typically stored in a container that includes a seal that can be penetrated by a spike attached to a tube and patient access tip. Together, the spike, tube, and patient access tip are frequently referred to as a ‘spike kit.’ In conventional systems, formula containers and spike kits are provided as separate components, requiring a caregiver to ‘spike’ a container prior to delivering the formula to the patient. That is, a caregiver must separately obtain a container of formula and a spike kit, assemble the separate components into a complete system, activate the spike kit by passing a portion through the seal on the container, and finally prepare the patient and the spiked formula container for delivery to the patient.
The use of conventional formula containers and spike kits has several drawbacks, particularly in the clinical setting. For example, because the act of ‘spiking’ the container involves the collection and handling of multiple components, an opportunity to introduce contamination into the nutritional composition is created. Considering the direct route the composition will take into the patient, contaminated formula can lead to infection, including serious and difficult to treat nosocomial infections. Contaminated formula can also lead to microbial growth in the feeding tube, necessitating its flushing and/or replacement. Furthermore, the need for an assembly step for the separate components creates a Hazard Analysis Critical Control Point (HACCP), which must be monitored for quality control by the health care provider. To manage risk at the spiking HACCP, health care providers frequently conduct training on proper methods to spike formula containers. Over time, this training grows to be both costly and time-consuming as it is often repeated to address personnel changes and the need for reinforcement.
There is, therefore, a need in the art for an integrated storage and delivery system for nutritional compositions and other fluids.